Robot-Assisted US-Based Vertebral Segmentation for Pedicle Screw Trajectory Identification

Summary

This other clinical trial compares robot-assisted US scanning with handheld US scanning and ground-truth CT data of the lumbar spine in healthy, young volunteers. The main questions it aims to answer are:

* Is a 3D reconstruction of a lumbar spine from robot-assisted US scanning equivalent to or better quality than a 3D reconstruction from handheld US scanning?
* Can a machine learning algorithm automatically segment the bone anatomy from robot-assisted and handheld US scanning to generate 3D lumbar spine reconstructions?
* Can pedicle screw trajectories be identified based on posterior vertebral landmarks of 3D reconstructions of lumbar spines from both robot-assisted and handheld US scanning?

Participants will:

* fill out a medical history questionnaire
* get clinically examined
* have an ultra-low-dose (ULD) CT Scan of the vertebra L1 to S1
* have a handheld US scan of the vertebra L1 to S1
* have a robot-assisted US Scan of the vertebra L1 to S1
* fill out a post-study questionnaire

Conditions

• Healthy

Interventions

OTHER

Robot-assisted US Scan of the vertebra L1 to S1

A standardized robot-assisted US-Scan of the vertebra L1 to the S1 is executed. The two probe trajectories are generated automatically by an optical camera or RedGreenBlue-Depth (RGB-D) camera. Then the robot will scan at two mm/s, automatically following the trajectory. A 6 degrees of freedom (DoF) force sensor (Nano25, Ati Industrial Automation Inc.) was assembled at the US probe. During the scanning, it measures the interaction force and torque between the US probe and volunteers' skin to ensure volunteer safety. The US images and corresponding robot poses are recorded for the reconstruction. A previously developed algorithm is used to obtain a preliminary 3D reconstruction that will be used to adapt the scanning pattern in case of incomplete scanning.

OTHER

Handheld US scan of the vertebra L1 to S1

A handheld US-Scan of the vertebra L1 to S1 is executed. An optical marker for an Atracsys Camera is mounted to the US probe to track its position. Simultaneously, the optical tracking allows for standardization of the US-Scan through navigation. The acquired US images and corresponding poses are used to reconstruct the lumbar spines and compared to the ground truth (CT scan). Handheld US scanning will be performed at around two mm/s in two scanning trajectories. The US probe orientation will be adjusted during the scanning by comparing the optical marker orientation with the initial probe orientation. This combination leads to different scanning patterns. For each pattern, the scanning procedure will be repeated three times. At least once per volunteer, each handheld scanning pattern will be performed with a higher manual speed to assess the reconstruction quality with faster scanning. A graphical user interface (GUI) will synchronize and store the data during the scanning.

RADIATION

ULD CT scan of the vertebra L1 to S1

A ULD CT scan (CT, Siemens Naeotom Alpha: A-207883-62) of the lumbar spine (L1-S1) is performed at the Swiss Center for Musculoskeletal Imaging (SCMI) at Balgrist Campus, Zurich. The total duration estimate for the CT examination is 30 minutes, whereas the scan takes 15 minutes. The volunteers lie on their abdomen during this procedure to simulate the spine's position during the subsequent US examination. The vertebrae (L1-S1) in the CT Scans are manually segmented with global thresholding and the region growing tool in a standard segmentation software (Materialise Mimics, Leuven, Belgium). The 3D surface models are then exported as Standard Triangle Language (STL) files.

Sponsors & Collaborators

• Swiss Center for Musculoskeletal Imaging

  collaborator UNKNOWN

• KU Leuven

  collaborator OTHER

• Philipp Fürnstahl

  lead OTHER

Principal Investigators

• Philipp Fürnstahl, PhD · Balgrist University Hospital

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-05-15

Primary Completion

2023-06-09

Completion

2023-06-09

Countries

• Switzerland

Study Locations